Monday, December 12, 2011

Under Industry Pressure, USDA Works to Speed Approval of Monsanto’s Genetically Engineered Crops
By Mike Ludwig
Truthout
December 12, 2011

For years, biotech agriculture opponents have accused regulators of working too closely with big biotech firms when deregulating genetically engineered (GE) crops. Now, their worst fears could be coming true: under a new two-year pilot program at the USDA, regulators are training the world’s biggest biotech firms, including Monsanto, BASF and Syngenta, to conduct environmental reviews of their own transgenic seed products as part of the government’s deregulation process.

This would eliminate a critical level of oversight for the production of GE crops. Regulators are also testing new cost-sharing agreements that allow biotech firms to help pay private contractors to prepare mandatory environmental statements on GE plants the United States Department of Agriculture (USDA) is considering deregulating.

The USDA launched the pilot project in April and, in November, the USDA announced vague plans [3] to “streamline” the deregulation petition process for GE organisms. A USDA spokesperson said the streamlining effort is not part of the pilot project, but both efforts appear to address a backlog of pending GE crop deregulation petitions that has angered big biotech firms seeking to rollout new products.

Documents obtained by Truthout under a Freedom Of Information Act (FOIA) request reveal that biotech companies, lawmakers and industry groups have put mounting pressure on the USDA in recent years to speed up the petition process, limit environmental impact assessments and approve more GE crops. One group went as far as sending USDA Secretary Tom Vilsack a timeline of GE soybean development that reads like a deregulation wish list. [Click here [4] and here [5] to download and read some of the documents released to Truthout.]

The pilot program is named the NEPA Pilot Project, after the National Environmental Protection Act (NEPA), which mandates that agencies prepare statements on the potential environmental impacts of proposed actions by the federal government, such as deregulating transgenic plants. On July 14, USDA officials held a training workshop to help representatives from biotech firms (see a full list here [6]) to understand the NEPA process and prepare Environmental Reports on biotech products they have petitioned the USDA to deregulate.

Regulators can now independently review the Environmental Reports and can use them to prepare their own legally mandated reviews, instead of simply reviewing the company’s petitions for deregulation. The pilot project aims to speed up the deregulation process by allowing petitioning companies to do some of the legwork and help pay contractors to prepare regulatory documents and, for its part, the USDA has kept the pilot fairly transparent [7]. A list [8] of 22 biotech seeds that could be reviewed under the pilot program includes Monsanto drought-tolerant corn [9], a “non-browning” apple, freeze tolerant eucalyptus trees and several crops engineered to tolerate the controversial herbicides glyphosate [10] and 2,4 D [11].

Activists say biotech firms like Monsanto are concerned only with profit and routinely supply regulators with one-sided information on the risks their GE seeds - and the pesticides sprayed on and produced by them - pose to consumers, animals and the agricultural environment. (The Natural Society recently declared [12] Monsanto the worst company of 2011.) Bill Freese, a policy expert with the Center for Food Safety (CFS), told Truthout that the NEPA pilot gives already powerful biotech companies too much influence over the review process.

“It’s the equivalent of letting BP do their own Environmental Assessment of a new rig,” Freese said.

Monsanto Goes to Court

Freese and the Center for Food Safety have been on the frontlines of the battle to reform the USDA’s regulatory approval process for GE crops. The group was a plaintiff in recent lawsuits challenging the deregulation - which basically means approval for planting without oversight - of Monsanto’s patented alfalfa and sugar beets that are genetically engineered to tolerate glyphosate-based Roundup herbicide. Farmers can spray entire fields of Monsanto’s “Roundup Ready” crops with Roundup to kill unwanted weeds while sparing the GE crops, but in recent years, some weeds have developed a tolerance to glyphosate, Roundup’s active ingredient. The cases kept the crops out of America’s fields for years and prompted biotech companies to put heavy pressure on top USDA officials to streamline and speed up the deregulation process, practically setting the stage for the NEPA pilot underway today.

Under NEPA, agencies like the USDA must prepare an Environmental Assessment (EA) to determine if the proposed action, such as deregulating a transgenic organism, would have an impact on the environment. If some type of significant impact is likely, the agency must then prepare a more in-depth Environmental Impact Statement (EIS) to explore potential impacts and alternative actions. NEPA requires an EIS for actions “significantly affecting the quality of the human environment.” Preparing a full impact statement for a biotech plant implies the government does not think GE crops are safe and the biotech industry has routinely butted heads with environmentalists while attempting to convince regulators and consumers otherwise. In the Monsanto beets and alfalfa cases, the CFS and other plaintiffs argued that the USDA should have prepared an EIS, not just a simple EA, before deregulating both Monsanto crops.

In the alfalfa case, the CFS and its co-plaintiffs claimed the crop could have significant impacts by crossbreeding and contaminating conventional and organic alfalfa with transgenes. They also argued the crop would increase the use of herbicides and promote the spread of herbicide-tolerant weeds known as “super weeds.” A federal district court agreed and vacated the USDA’s original approval, halting plantings across the country. Monsanto challenged the decision and the alfalfa case landed in the Supreme Court in 2010 [14]. The high court overturned an injunction preventing farmers from planting the alfalfa, but also ordered the USDA to prepare an EIS and issue another deregulation decision. The sugar beet case ended in similar fashion and the USDA recently released a draft EIS on the crop, which is expected to be deregulated in early 2012.

Monsanto won [15] the right to sell its GE alfalfa seed in February 2011, but the lengthy and expensive legal battle captured the attention of food lovers and agriculturalists across the country. Americans debated the potential dangers of GE crops and the merits of the regulatory system that is supposed to protect farmers and consumers. As documents unearthed by a Truthout FOIA request reveal, the biotech industry did not sit idly by as activists challenged the regulatory status quo.

Mounting Pressure

The Biotechnology Industry Organization (BIO) is a powerful group that represents dozens of biotech companies such as Monsanto, BASF and Bayer, and has spent more than $67 million [16] lobbying Congress since 2000. In April 2010, BIO sent a letter to USDA Secretary Tom Vilsack as the Monsanto alfalfa case made its way through the courts. BIO warned Vilsack that the American biotech agriculture industry could be crippled if the legal precedents required the USDA to prepare an EIS for every GE crop up for deregulation:

With 19 deregulation petitions pending with more on the way, requiring an EIS for each product would amount to a de facto moratorium on commercialization and would send an unprecedented message that USDA believes that these products do have an environmental impact, when in fact most do not. Any suggestion by USDA that biotechnology plants as a category are likely to cause significant adverse effects on the quality of the human environment (i.e., require an EIS) would make approvals by other trading partners virtually impossible …

BIO claimed that such a policy would be an “over-reaction to the current judicial decisions” and would threaten America’s economic dominance in the agricultural biotechnology market. Such a policy, BIO representatives stated, would send a message to European countries that American regulators believe GE crops impact the environment, making approvals of GE crops by the European Union “virtually impossible” and allowing “Brazil and China to surpass the United States as world leaders in biotechnology.” BIO also claimed that more rigorous assessments would “undercut” positions consistently take by the Obama and Bush administrations on the safety of biotech agriculture.

Vilsack received similar letters requesting the USDA continue relying on EAs instead of EISs to deregulate GE crops from the Americas Soybean Association and the American Seed Trade Association. Both groups worried that an increase in oversight - precipitated by the more in-depth impact evaluation - could back up approvals for years. The soybean association included in its letter a pipeline chart of 25 GE soybean varieties it “expected” to be approved for commercialization within a decade.

A policy requiring an EIS for every GE seed is exactly what critics of Monsanto and the rest of the industry have spent years fighting for. Unlike the industry, they believe the herbicides that blanket GE crops and the potential for transgenic contamination are potential threats to the agricultural environment and human health.

Vilsack wrote a steady-handed reply to each trade group, reassuring them that the NEPA policy would not change and the USDA would continue preparing an EA for new GE seeds and an EIS only when necessary. Vilsack also wrote that he was “pleased” to recently meet with biotech industry representatives and “discuss improving the efficiency of the biotechnology regulatory process.” Such improvements, he wrote, are “directly related” to the USDA’s “objective of ensuring the United State leads the world in sustainable crop production and biotech crop exports.” He took the opportunity to announce that the USDA would reorganize the Biotechnology Regulatory Services agency and create a new NEPA team “dedicated to creating high quality and defensible documents to better inform our regulatory decisions.” This new NEPA team would go on to develop the NEPA Pilot Project and begin streamlining the approval process.

To Freese, it appears that Vilsack used to the word “defensible” in reference to legal challenges like the ones his group made to Monsanto alfalfa and sugar beets. “Their whole focus is on ‘defensible’ Environmental Assessments,” Freese said after reading the letters. “From our perspective, that’s the wrong goal … it presumes the crop is going to be approved.”

Freese said the correspondence between Vilsack and the industry groups highlights the need for a culture change at the USDA. Regulators should be concerned about the safety of new GE products, not ensuring American exports compete with Brazil and China.

“It should be all about doing good assessments and making sure the crops that are approved are safe,” Freese said.

A USDA spokesperson declined to comment when asked if the agency would like to respond to criticisms of the NEPA Pilot Project and said updates on the project will be made available online.

Watchdogs like Freese know that regulators already work closely with the industry and the NEPA Pilot Project could simply make their work more efficient. Regulators already rely heavily on data provided by private contractors and by biotech companies to prepare EAs. During the Monsanto alfalfa case, internal emails between regulators and Monsanto officials surfaced [17] and revealed the company worked closely with regulators to edit its original petition to deregulate the alfalfa. One regulator even accepted Monsanto’s help in conducting the USDA’s original EA of the GE alfalfa before it was initially approved in 2005.

Genetically engineered and modified crops continue to cause controversy across the globe, but in America they are a fact of life. The Obama and Bush administrations have actively promoted biotech agriculture both at home and abroad [18]. Countries like China, Argentina and Brazil have also embraced biotech agriculture. Regulators in European countries - including crucial trade partners like France and Spain - have been much more cautious and, in some cases, even hostile toward the industry. GE crops are banned in Hungary and Peru, and earlier this year officials in Hungary destroyed [19] 1,000 acres of corn containing Monsanto transgenes. The US, however, continues to allow big biotech companies to cultivate considerable power and influence and, as the letters uncovered by FOIA reveal, top regulators are ready to meet their demands.

“The USDA regards its own regulatory system as a rubber stamp,” Freese said after reading the letters. “At least at the upper levels, there’s always been this presumption that [GE crops] must be approved.”